Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure

PHASE3CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

July 15, 2020

Primary Completion Date

September 9, 2024

Study Completion Date

September 9, 2024

Conditions
HemorrhageUrgent SurgeryInvasive Procedure
Interventions
DRUG

Bentracimab (PB2452) Infusion

"Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration.~In subjects with potential drug interaction from recent concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36g infusion.~In patients presenting with intracranial hemorrhage (ICH), brain imaging within 2 hours of initiation of study drug and at least one follow-up brain imaging performed 12-24 hours post completion of PB2452."

Trial Locations (68)

1160

Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care Medicine, Vienna

2650

University Hospital Antwerp Cardiology Department - Clinical Trials, Edegem

3100

Klinische Abteilung für Innere Medizin 3 Universitätsklinikum St. Pölten, Sankt Pölten

3500

Jessa Hospital Hartcentrum Hasselt Research Center, Hasselt

3600

Ziekenhuis Oost-Limburg Study Center Intensive Care, Genk

4031

Universitatsspital Basel Department of Cardiology, Basel

6900

Cardiocentro Ticino, Lugano

8000

AZ Sint-Jan Brugge-Oostende AV Poli Cardiologie, Bruges

8036

Medical University Of Graz, Graz

9300

Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology, Aalst

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

20089

Istituto Clinico Humanitas UO Cardiologia Clinica e Interventistica, Rozzano

20090

ASST Monza - Ospedale San Gerardo, Monza

21215

Sinai Hospital of Baltimore, Baltimore

22185

Skane University Hospital, Department of Cardiology, Lund

28007

Hospital Universitario 12 de Octubre, Residencia general, Madrid

28040

Hospital Universitario Vírgen de la Victoria, Málaga

32209

University of Florida Health, Jacksonville, Jacksonville

37170

CHRU de Tours - Hopital Trousseau Service de Cardiologie-USCI 2 eme etage, Tours

40536

University of Kentucky, Lexington

41009

Hospital Universitario Virgen Macarena, Seville

43126

Azienda Ospedaliero-Universitaria di Parma Cardiologia, Parma

45000

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

48202

Henry Ford Hospital, Detroit

58104

Sanford Medical Center Fargo, Fargo

59037

CHU de Lille Service USIC, Institut Coeur Poumon, Lille

64116

North Kansas City Hospital, North Kansas City

65807

Cox Medical Centers, Springfield

67063

Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen

74104

Ascension St. John Clinical Research Institute, Tulsa

75013

Assistance Publique-Hopitaux de Paris (AP-HP) Pitie-Salpetriere Hospital, Paris

75018

Bichat Hospital, Service de Cardiologie, Paris

100029

Beijing Anzhen Hospital, Capital Medical University, Beijing

100034

Peking University First Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100083

Peking University Third Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

130041

The Second Affiliated Hospital of Jilin University, Changchun

150001

The First Affiliated Hospital of Harbin Medical University, Harbin

200080

Shanghai General Hospital, Shanghai

215031

First Affiliated Hospital of Soochow University, Suzhou

223300

Huai'an First People's Hospital, Huai'an

300052

Tianjin Medical University General Hospital, Tianjin

300222

Tianjin Chest Hospital, Tianjin

310000

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

310009

Medidata, Hangzhou

330006

The Second Affiliated Hospital of Nanchang University, Nanchang

430014

The Central Hospital of Wuhan, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

550002

Guizhou Provincial People's Hospital, Guiyang

730030

Lanzhou University Second Hospital, Lanzhou

750004

General Hospital of Ningxia Medical University, Yinchuan

02903

Rhode Island Hospital, Providence

T2N 2T9

Foothills Medical Centre, Calgary

E2L 4L2

Saint John Regional Hospital, Saint John

M9V 1R8

William Osler Health System, Etobicoke

L8L 2X2

Hamilton Health Sciences Centre, Hamilton

ON K7L 2V7

Kingston Health Science Centre, Kingston

L3Y 2P7

York PCI Group, Inc., Newmarket

M5B 1W8

St. Michael's Hospital, Unity Health Toronto, Toronto

M5G 2C4

Toronto General Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

7512 KZ

Medisch Spectrum Twente, Enschede

3435 CM

St Antonius Hospital, Nieuwegein

08035

Hospital Universitario Vall d'Hebron, Barcelona

413 45

Sahlgrenska University Hospital, Gothenburg

SG1 4AB

East and North Hertfordshire, NHS Trust, Lister Cardiac Research Office, Cardiology Green Zone, Lister Hospital, Stevenage

S5 7AU

Sheffield Teaching Hospitals, NHS Foundation Trust, Northern General Hospital, Sheffield

All Listed Sponsors
lead

SFJ Pharmaceuticals, Inc.

INDUSTRY

NCT04286438 - Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure | Biotech Hunter | Biotech Hunter